Albumin Human (Systemic)


VA CLASSIFICATION
Primary: BL800

Commonly used brand name(s): Albuminar-25; Albuminar-5; Albutein 25%; Albutein 5%; Buminate 25%; Buminate 5%; Plasbumin-25; Plasbumin-5.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Blood volume expander—

antihyperbilirubinemic—

Indications

General considerations
The benefit of administration of albumin to seriously ill patients is currently controversial. A meta-analysis of randomized, controlled clinical studies of albumin use revealed excess mortality of approximately 6% (i.e., 1 excess death per 17 treated patients) for combined groups of patients with hypovolemia, burns, or hypoproteinemia who received albumin either instead of or in addition to crystalloid solutions {68}. Also, for each of these patient subgroups, the risk of death in the albumin-treated group was higher than in the comparison group {68}.

In response to this meta-analysis, the United States Food and Drug Administration suggested physicians exercise discretion in the use of albumin based on their own assessment of the above data until the results of further, well-focused studies are available. {69} However, the recently published meta-analysis has received criticism from a number of clinicians. Some of the arguments against the validity of the conclusions drawn from the review involve the fact that the individual studies reviewed were heterogeneous, comparing different disease states, age groups, study designs and endpoints, and that the cause of death was ignored. Other concerns include the small number of patients included in the majority of the studies (17 out of 32 studies included 30 patients or less [range in all studies, 12–219]); the age of many of the studies; and the use of multiple methods of albumin administration, some of which may be outdated. {70}

Current treatment guidelines such as those of the Subcommittee of the Victorian Drug Usage Advisory Committee {58} and the University Hospital Consortium {60} should be consulted until further information concerning albumin administration is available, while recognizing that these guidelines themselves may require change {69}.

Accepted

Hypovolemia (treatment)—The 5 and 25% concentrations of albumin are indicated in the emergency treatment of hypovolemia with or without shock. Albumin restores intravascular volume and maintains cardiac output and colloid oncotic pressure. If blood loss is severe, a transfusion of whole blood or red blood cells may be indicated to restore the hemoglobin concentration and improve oxygen transport. {01} {02} {03} {04} {05} {06} {07} {08} {15} {16} {19} {21} {27} {32} {34} {37} {39} {42} {43} {45} {46} {49} {59}

Hypoproteinemia (treatment)—The 25% concentration of albumin is indicated in the treatment of hypoproteinemia caused by loss of plasma proteins. {73} Although the 5% concentration of albumin has been used, the 25% concentration is preferred. {71}
—Loss of plasma proteins may occur through decreased absorption in gastrointestinal disorders, inadequate synthesis in chronic liver disease, or excessive urinary loss and increased catabolism in chronic kidney disease. This loss of protein leads to edema secondary to a fluid shift from the intravascular space to the interstitium and a compensatory increase in salt and water retention. Albumin serves to restore colloid oncotic pressure and, in conjunction with a diuretic, promote diuresis. {01} {02} {03} {04} {05} {06} {07} {08} {13} {21} {27} {32} {39} {42} {43} {45} {46} {49} {59}
—The Subcommittee of the Victorian Drug Usage Advisory Committee (SVDUAC) states albumin use may be appropriate when the serum albumin is less than 25 grams per liter (g/L) and accompanied by edema and/or possibly clinically significant hypernatremia. {58} {72} Albumin also may be appropriate for use in extremely low hypoalbuminemia in critically ill patients {58} {72}.

Burns, severe (treatment adjunct)—The 5 and 25% concentrations of albumin are indicated, in conjunction with large volumes of crystalloid injection, to maintain plasma volume and protein concentration and to prevent the intravascular hemoconcentration accompanying severe burns {01} {02} {04} {05} {06} {07} {13} {14} {15} {24} {32} {37} {38} {39} {43} {46} {49} {59}.

Hyperbilirubinemia, neonatal (treatment)—The 25% albumin injection is indicated in the treatment of hyperbilirubinemia whether or not it is associated with hemolytic disease. It may be used prior to or during an exchange transfusion to bind free bilirubin and to enhance its removal. {01} {05} {28} {32} {39} {43} {45} {46} {49}

Respiratory distress syndrome, adult (ARDS) (treatment adjunct) —The 25% albumin injection may be indicated, in conjunction with diuretics, to correct the fluid volume overload associated with ARDS {01} {05} {13} {14} {15} {18} {23} {32} {39} {43} {45} {49}.

Cardiopulmonary bypass (treatment adjunct)—The 5 and 25% concentrations of albumin may be indicated as adjuncts to provide hemodilution in cardiopulmonary bypass procedures {01} {03} {04} {05} {06} {07} {14} {23} {32} {39} {43} {45} {46} {49}.

Ascites (treatment adjunct)1—The 5 and 25% concentrations of albumin may be used to maintain cardiovascular function following the removal of large volumes of ascitic fluid {01} {07} {15} {21} {23} {32} {45} {58}.

Nephrosis, acute (treatment adjunct) or
Nephrotic syndrome, acute (treatment adjunct)— The 25% albumin injection may be indicated as an adjunct in the control of edema in patients refractory to cyclophosphamide and corticosteroid therapy {01} {05} {15} {23} {32} {39} {43} {45} {49}.

Hemodialysis—The 25% albumin injection may be used as an adjunct in patients who are undergoing long-term hemodialysis and are susceptible to shock and hypotension, or in dialysis patients who are hypervolemic and may not tolerate large volumes of crystalloid injection as treatment for shock or hypotension {03} {15} {23} {27} {32} {43} {45} {46} {49}.

Pancreatitis (treatment adjunct) or
Intra-abdominal infections (treatment adjunct)— The 5 and 25% concentrations of albumin may be indicated, along with crystalloids, as fluid replacement in the treatment of shock associated with acute hemorrhagic pancreatitis or peritonitis when there is loss of fluid into the third space {01} {04} {07} {18} {22} {25} {32} {37} {43}.

Liver failure, acute (treatment adjunct)—The 5 and 25% concentrations of albumin may be indicated as adjuncts in the treatment of acute liver failure to stabilize the circulation, maintain plasma colloid oncotic pressure, and bind excess bilirubin {01} {04} {07} {15} {32} {43} {45} {49}.

Red blood cell resuspension—Albumin may be indicated to provide sufficient volume and to prevent excessive hypoproteinemia during certain types of exchange transfusions or during the administration of large volumes of previously frozen or washed red blood cells {01} {04} {07} {15} {32} {43} {49} {55}.

[Plasmapheresis1]—The 5% concentration of albumin is indicated as volume or fluid replacement in large-volume plasma exchange, which is defined as more than 20 mL per kg in one session, or more than 20 mL per kg per week in repeated sessions {58} {60} {61}.

Unaccepted
Albumin has not been shown to be effective in the treatment of chronic cirrhosis or nephrosis {04} {05} {07} {15} {23} {32} {43} {49}.

Albumin does not contain all the essential amino acids and, therefore, is not an appropriate source of protein in the treatment of malnutrition. Given in excessive amounts, albumin may increase the catabolism of endogenous albumin. {01} {03} {04} {05} {06} {07} {08} {13} {15} {23} {29} {32} {39} {43} {45} {49}

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    Obtained from source blood, plasma, serum, or placentas of healthy human donors {12} by fractionation according to the Cohn cold ethanol process {02} {03} {04} {05} {06} {07} {13} {14} {32} {36} {39} {43} {45} {59}.
    Albumin is heat pasteurized for 10 hours at 60 °C to inactivate human immunodeficiency virus (HIV) {10} {36} {47} {51} {52} {53} {54} {55} {58} and hepatitis viruses {01} {02} {03} {04} {05} {06} {07} {10} {13} {14} {21} {32} {33} {36} {39} {43} {45} {46} {48} {49} {58} {59}; sodium caprylate and sodium acetyltryptophanate are added to prevent denaturation during this process {01} {02} {03} {04} {05} {06} {07} {23} {32} {39} {43} {45} {46} {49} {59}.
Molecular weight—
    66,300 to 69,000 {01} {03} {05} {14} {16} {34} {36} {45} {48} {49}


pH
    6.4 to 7.4 {01} {02} {03} {05} {06} {23} {39} {45} {46} {49} {59}.

Mechanism of action/Effect:

Blood volume expander—Albumin is an important regulator of the volume of circulating blood. It accounts for 70 to 80% of the colloid oncotic pressure of plasma. An infusion of albumin 5% is oncotically equivalent to an equal volume of human plasma and increases blood volume by an amount approximately equal to the volume of albumin infused; albumin 25% is oncotically equivalent to approximately 5 times the volume of human plasma and draws into the circulation an amount of fluid approximately 3.5 times the volume of albumin infused. Albumin provides a temporary {48} increase in blood volume, which reduces hemoconcentration and blood viscosity. {01} {02} {03} {04} {05} {06} {07} {32} {36} {39} {43} {45} {49} {59}

Antihyperbilirubinemic—Albumin is a transport protein that reversibly {15} {26} binds both endogenous and exogenous substances including bilirubin {13} {28}, fatty acids, hormones, enzymes, drugs, dyes, and trace metals {01} {02} {03} {05} {06} {07} {13} {15} {32} {39} {45} {49} {59}.

Distribution:

Albumin is distributed throughout the extracellular water; more than 60% is located in the extravascular fluid compartment {01} {03} {05} {06} {13} {39} {45} {49}.

Half-life:

Elimination—15 to 20 days {01} {03} {05} {06} {09} {15} {23} {39} {45} {47} {49}.

Other—Intravascular: 24 hours {34}.

Onset of action:

Blood volume expansion—With albumin 25% injection: 15 minutes, provided the patient is well hydrated {01} {02} {03} {04} {05} {06} {07} {32} {39} {43} {45} {48} {59}.

Duration of action:

Dependent upon the initial blood volume of the patient. If blood volume is reduced, volume expansion persists for many hours; however, if blood volume is normal, the effect lasts a shorter time. {01} {02} {03} {04} {05} {06} {07} {23} {32} {39} {43} {45} {49} {59}


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans.

Studies have not been done in animals {01} {02} {03} {04} {05} {06} {07} {32} {39} {43} {45} {49} {59}.

FDA Pregnancy Category C {01} {02} {03} {04} {05} {06} {07} {32} {39} {43} {45} {49} {59}.

Breast-feeding

It is not known whether albumin is distributed into breast milk. However, problems in humans have not been documented.

Pediatrics

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of albumin in children {05} {06} {39}.


Geriatrics


No information is available on the relationship of age to the effects of albumin in geriatric patients.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problems exist:
» Anemia, severe {01} {02} {03} {04} {05} {06} {07} {28} {32} {39} {43} {45} {46} {49} {59} or
» Cardiac failure {01} {02} {03} {04} {05} {06} {07} {13} {23} {28} {32} {39} {43} {45} {46} {49} {59} or
» Hypervolemia {03} {28} or
» Pulmonary edema {01} {46}    (these medical problems may increase the risk of and/or be exacerbated by circulatory overload)


Risk-benefit should be considered when the following medical problems exist
Hypertension {05} or
Normal serum albumin concentrations {02} {04} {43} {59}    (increased plasma volume may lead to circulatory overload; hypertension may be exacerbated)


Renal function impairment {01} {09} {30} {31} {44}    (aluminum, sometimes present as a contaminant in albumin injections, may accumulate, leading to anemia, dialysis encephalopathy, hypercalcemia, or vitamin D-refractory osteomalacia)


Sensitivity to albumin {01} {03} {04} {05} {06} {07} {32} {39} {43} {45}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Aluminum concentrations, serum {30}    (recommended in patients with renal function impairment, who are infused repeatedly with large volumes of albumin {47})


» Blood pressure measurements {01} {02} {03} {04} {05} {06} {07} {32} {39} {43} {45} {49} {59}    (a rapid rise in blood pressure may reveal bleeding that was not apparent at the lower blood pressure)


Pulmonary wedge pressure determinations {01} {49}    (recommended to guard against circulatory overload)




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent
    
Congestive heart failure{19}{23} —especially in patients with compromised cardiovascular function
    
decreased myocardial contractility{09}{19}{33}
    
pulmonary edema{09}{19}{20}{40}
    
salt and water retention{09}{19}{20}{33}{35}

Note: These side effects are more likely to occur in patients given large volumes of crystalloids prior to the administration of albumin {52}.


Incidence rare
    
Changes in blood pressure, pulse, and respiration{01}{03}{04}{07}{09}{32}{43}{45}{46}
    
chills{01}{03}{04}{05}{06}{07}{14}{23}{32}{39}{43}{45}{46}{49}
    
fever{01}{02}{03}{04}{05}{06}{07}{09}{14}{23}{32}{39}{43}{45}{46}{49}{59}
    
increased salivation{02}{46}{59}
    
nausea{01}{02}{03}{05}{06}{09}{23}{39}{45}{46}{49}{59} or vomiting{01}{03}{45}{46}
    
skin rash or hives{01}{02}{03}{04}{05}{06}{07}{09}{14}{23}{32}{33}{34}{39}{43}{45}{46}{59}
    
tachycardia{01}{03}{09}{45}





General Dosing Information
Albumin contains no blood group isoagglutinins and, therefore, may be given without regard to the blood group of the patient {01} {02} {05} {06} {39} {49} {59}.

Albumin must be administered by intravenous infusion {01} {02} {03} {04} {05} {06} {07} {32} {39} {43} {45} {49} {59}. It may be administered without dilution {02} {05} {59} or diluted with 0.9% sodium chloride injection or 5% dextrose injection {01} {02} {03} {04} {05} {06} {07} {32} {39} {43} {45} {49} {59}. Sterile water for injection must not be used as a diluent for 25% albumin solutions as this results in a substantial reduction in osmolarity (tonicity), which increases the risks for potentially fatal hemolysis and acute renal failure, particularly when large volumes of the diluted solution are used in plasmapheresis {62}. It also may be administered with plasma {05} {06} {39}, packed red blood cells {01} {04} {07} {32} {43}, or whole blood; however, except when used as a red blood cell resuspension medium, albumin {01} {02} {04} {05} {06} {07} {32} {39} {43} {49} {59} should not be added directly to any of these three components {50} {53} {54} {55} {56} {57}.
Note: Although 5% dextrose injection is considered an acceptable diluent, when it is used to dilute 25% albumin solutions and the resulting solution is used in the setting of plasma exchange or in conjunction with red blood cells, hemolysis might occur {63} {64}. Also, infusion of large volumes of the diluted solution can result in hyponatremia {65}. Therefore, some clinicians recommend using only 0.9% sodium chloride injection as the diluting fluid except when there is concern about increasing the patient's sodium load and/or there is a need to maintain or restore the patient's blood glucose concentration {63} {64} {65}.



Albumin may be administered at a rate of 1 to 2 mL per minute {01} {02} {03} {45} {49} {59}; however, the rate of infusion and the total volume of albumin administered ultimately must be guided by the hemodynamic response of the patient {01} {02} {03} {04} {05} {43} {45} {49} {59}.

Patients with marked dehydration given 25% albumin injection require administration of additional fluids {03} {04} {07} {32} {43} {45} {46}.

Transfusions of whole blood or packed red blood cells may be necessary following administration of large volumes of albumin to restore hemoglobin concentration and to prevent anemia {02} {04} {05} {06} {07} {32} {39} {43} {59}.


Parenteral Dosage Forms

ALBUMIN HUMAN USP

Usual adult dose
Hypovolemia
Intravenous infusion, 25 grams as a 5 or 25% injection, administered as rapidly as tolerated by the patient {01} {02} {03} {05} {06} {39} {45}. If an adequate response is not achieved within fifteen {03} {05} {39} {45} {59} to thirty {02} {03} {05} {06} {39} {45} {59} minutes, an additional dose may be given.

Hypoproteinemia
Intravenous infusion, 50 to 75 grams as a 25% injection {32} {59}, administered at a rate of 100 mL over thirty to forty minutes. For slow infusion, 50 grams in 300 mL of 10% dextrose injection, administered at a rate of 100 mL per hour {59}.

Burns
Therapy is usually begun with the administration of large volumes of crystalloid injection to maintain plasma volume {02} {04} {07} {17} {32} {43} {49} {59}. After 24 hours, albumin may be added at an initial dose of 25 grams {06}, with the dose adjusted thereafter to maintain a plasma albumin concentration of 2.5 grams per 100 mL (25 grams/L), or a total serum protein concentration of 5.2 grams per 100 mL (52 grams/L) {02} {04} {07} {15} {43} {59}.

Cardiopulmonary bypass
Intravenous infusion, as a 5 or 25% injection, with crystalloid as a pump prime to achieve plasma albumin and hematocrit concentrations of 2.5 grams per 100 mL (25 grams/L) and 20%, respectively {01} {04} {07} {15} {32} {43} {49}.

Nephrosis, acute or
Nephrotic syndrome, acute
Intravenous infusion, 25 grams as a 25% injection, administered with an appropriate diuretic once a day for seven {01} {32} {43} {49} to ten {32} {43} days.

Hemodialysis
Intravenous infusion, 25 grams as a 25% injection {15} {32} {43} {49}.

Red blood cell resuspension
20 {49} to 25 grams as a 25% injection, per liter of red blood cells {15} {43} {49}.


Usual adult prescribing limits
Up to 2 grams per kg of body weight within twenty-four hours {01} {02} {04} {05} {06} {07} {32} {39} {43} {49} {59}.

Usual pediatric dose
Hypovolemia
Intravenous infusion, 2.5 {02} to 12.5 grams {03} {45}, or 0.5 to 1 gram per kg of body weight {04} {05} {06} {07} {39}, administered as rapidly as tolerated by the patient. If an adequate response is not achieved within fifteen {03} {05} {45} to thirty {02} {03} {05} {06} {39} {45} {59} minutes, an additional dose may be given.

Burns
Therapy is usually begun with the administration of large volumes of crystalloid injection to maintain plasma volume {02} {04} {07} {17} {32} {43} {49} {59}. After 24 hours, albumin may be added at an initial dose of 25 grams {06}, with the dose adjusted thereafter to maintain a plasma albumin concentration of 2 {52} to 2.5 grams per 100 mL (20 to 25 grams/L), or a total serum protein concentration of 5.2 grams per 100 mL (52 grams/L) {02} {04} {07} {15} {43} {52} {59}.

Hyperbilirubinemia, neonatal
Intravenous infusion, 1 gram per kg of body weight {01} {05} {32} {39} {43} {45} {49} as a 25% injection, administered during {05} {06} {39} {45} {49}, or one to two hours prior {01} {04} {06} {07} {32} {39} {43} {49} to, exchange transfusion.


Strength(s) usually available
U.S.—


5% in 50 mL (Rx) [Albuminar-5 (sodium ion 130–160 mEq per L) (potassium ion £ 1 mEq per L)] [Plasbumin-5][Generic](sodium ion 130–160 mEq per L)


5% in 250 mL (Rx) [Albuminar-5 (sodium ion 130–160 mEq per L) (potassium ion £ 1 mEq per L)] [Albutein 5% (sodium ion 130–160 mEq per L)] [Buminate 5% (sodium ion 130–160 mEq per L)] [Plasbumin-5][Generic](sodium ion 130–160 mEq per L)


5% in 500 mL (Rx) [Albuminar-5 (sodium ion 130–160 mEq per L) (potassium ion £ 1 mEq per L)] [Albutein 5% (sodium ion 130–160 mEq per L)] [Buminate 5% (sodium ion 130–160 mEq per L)] [Plasbumin-5][Generic](sodium ion 130–160 mEq per L)


5% in 1000 mL (Rx) [Albuminar-5 (sodium ion 130–160 mEq per L) (potassium ion £ 1 mEq per L)]


25% in 20 mL (Rx) [Albuminar-25 (sodium ion 130–160 mEq per L) (potassium ion £ 1 mEq per L)] [Albutein 25% (sodium ion 130–160 mEq per L)] [Buminate 25% (sodium ion 130–160 mEq per L)] [Plasbumin-25][Generic](sodium ion 130–160 mEq per L)


25% in 50 mL (Rx) [Albuminar-25 (sodium ion 130–160 mEq per L) (potassium ion £ 1 mEq per L)] [Albutein 25% (sodium ion 130–160 mEq per L)] [Buminate 25% (sodium ion 130–160 mEq per L)] [Plasbumin-25][Generic](sodium ion 130–160 mEq per L)


25% in 100 mL (Rx) [Albuminar-25 (sodium ion 130–160 mEq per L) (potassium ion £ 1 mEq per L)] [Albutein 25% (sodium ion 130–160 mEq per L)] [Buminate 25% (sodium ion 130–160 mEq per L)] [Plasbumin-25][Generic](sodium ion 130–160 mEq per L)

Canada—


5% in 50 mL (Rx) [Plasbumin-5]


5% in 250 mL (Rx) [Plasbumin-5]


5% in 500 mL (Rx) [Plasbumin-5]


25% in 20 mL (Rx) [Plasbumin-25]


25% in 50 mL (Rx) [Plasbumin-25]


25% in 100 mL (Rx) [Plasbumin-25]

Packaging and storage:
Store at 15 to 30 °C (59 to 86 °F), unless otherwise specified by manufacturer. Protect from freezing. {01} {03} {04} {05} {06} {07} {32} {39} {43} {45}

Preparation of dosage form:
A 5% albumin solution may be prepared from the 25% solution by adding one volume of the 25% solution to four volumes of 0.9% sodium chloride injection or 5% dextrose injection. Sterile water for injection must not be used as a diluent for 25% albumin solutions as this results in a substantial reduction in osmolarity (tonicity), which increases the risks for potentially fatal hemolysis and acute renal failure, particularly when large volumes of the diluted solution are used in plasmapheresis {62}.

Note: Although 5% dextrose injection is considered an acceptable diluent, when it is used to dilute 25% albumin solutions and the resulting solution is used in the setting of plasma exchange or in conjunction with red blood cells, hemolysis might occur {63} {64}. Also, infusion of large volumes of the diluted solution can result in hyponatremia {65}. Therefore, some clinicians recommend using only 0.9% sodium chloride injection as the diluting fluid except when there is concern about increasing the patient's sodium load and/or there is a need to maintain or restore the patient's blood glucose concentration {63} {64} {65}.


Stability:
Should not be used if solution is turbid or contains a precipitate. Albumin contains no preservative and should be used within 4 hours after the vial is opened. {01} {02} {03} {04} {05} {06} {07} {12} {32} {39} {43} {45} {49} {59} Partially used vials should be discarded {01} {02} {03} {04} {05} {07} {32} {43} {45} {49} {59}.

Incompatibilities:
Albumin is incompatible with verapamil hydrochloride {11} {41}, alcohol-containing solutions {01} {03} {04} {05} {06} {07} {32} {39} {43} {45} {49}, amino acid solutions {01} {04} {07} {32} {43}, fat emulsions {41}, and protein hydrolysates {01} {03} {04} {05} {06} {07} {32} {39} {43} {45} {49}.



Revised: 08/17/1993



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